Page 75 - 2023 Taiwan Food and Drug Administration Annual Report
P. 75
5Improving Management of Medical
Devices and Cosmetics
Research Institute, which has greatly boosted III. Introduction of the
the zeal of all parties to devote themselves to e-submission and review
the R&D of medical devices. Furthermore, to system to improve the
increase the professionalism of practitioners, efficiency of digital
TFDA has promoted the medical device management
professional technician system. As of the
end of 2022, a total of 6,800 people had been On January 21, 2022, the e-submission
registered as medical device technicians and system for the registration and market
41 online courses had been provided as part of approval of medical devices was officially
continuing education for technicians. launched to facilitate the e-submission and
review of applications for registration and
II. Establishment of sound and market approval, contract manufacturing,
internationally harmonized alteration, and extension of Class 2 and Class
laws and regulations to 3 medical devices. As of the end of 2022, with
govern medical devices a total of 957 applications, one can see that the
system has helped to improve the convenience
In 2022, a total of 12 guidances or of submitting pre-market applications for
guidelines related to laws and regulations medical devices. In addition, on March 8, the
of medical devices or review were added or announcement of “Medical Device Product
revised, including 4 guidances or guidelines Items Whose Instructions May Be Replaced
related to artificial intelligence/machine- by Electronic Instructions and Medical Device
learning based technologies and pre-clinical Firms Shall Indicate the Particulars on the
testing/technical criteria for 8 preclinical Labels or Package” was made in an effort to
testing/benchmarks and guidance that promote paperless practice and digitalization.
manufacturers can use as references during the
phases of product development, verification, IV. Advancement in
and registration and market approval. In development of innovative
addition, the “Reference for the Use of Real medical devices
World Data and Real World Evidence To
Support Regulatory Decision-Making for To improve the service efficiency and
Medical Devices” was announced to facilitate effectiveness of the Intelligent Medical
proper utilization of such data by all parties Device Project Office, in 2022, the Office
and to expedite product development. actively solicited applications, which resulted
in 10 applications related to domestically
manufactured Artificial Intelligent/Machine
Learning-Based Software as a Medical
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